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| Name | Class |
|---|---|
| National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia | OTHER |
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The correlation of the morphologic, microbiological, genetic and histopathological characteristics of TB lesions obtained in therapeutical surgery with the clinical forms and features of the patients will provide essential information
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective cohort | Tuberculosis patients submitted to therapeutical surgery during the last 2-5 years. |
| |
| Prospective cohort | Tuberculosis patients prospectively submitted to therapeutical surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutical surgery for TB | Procedure | Patients undergoing therapeutical surgery for tuberculosis (DS- and MDR/XDR-TB) indicated as per clinical routine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Description of Clinical and Epidemiological Data of the TB patients enrolled | for both the Retrospective and Prospective Substudies; descriptive analysis; data recorded in a spreadsheet created ad-hoc | at baseline |
| Description of the Histopathological characteristics of the TB lesions of TB patients enrolled | for both the Retrospective and Prospective Substudies; descriptive analysis; data recorded in a spreadsheet created ad-hoc | at baseline |
| Obtention of a genic-proteomic profile of TB lesions tissues which correlate to the histopathology of the granulomas and/or the clinic-pathological features of TB patients | only for Prospective Substudy; descriptive analysis, correlation with histopathological characteristics of TB lesions and with clinical and epidemiological data of TB patients | at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Immunological responses | only for Prospective Substudy. Immunological responses will be measured 2.1.3. Identification of biomarkers in blood at protein level in blood and urine; validation in tissue and blood of genic biomarkers secreted (ELISA, qPCR, immunohistochemistry). | at baseline; and at the moment of discharge, an average of at day 15 post-enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing therapeutical surgery for their Pulmonary Tuberculosis at NCTLD in Tbilisi, Georgia
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Vilaplana, Dr | Fundació Institut Germans Trias i Pujol (IGTP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for Tuberculosis and Lung Diseases | Tbilisi | Georgia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28007659 | Result | Vashakidze S, Despuig A, Gogishvili S, Nikolaishvili K, Shubladze N, Avaliani Z, Tukvadze N, Casals M, Cayla JA, Cardona PJ, Vilaplana C. Retrospective study of clinical and lesion characteristics of patients undergoing surgical treatment for Pulmonary Tuberculosis in Georgia. Int J Infect Dis. 2017 Mar;56:200-207. doi: 10.1016/j.ijid.2016.12.009. Epub 2016 Dec 19. | |
| 32904577 |
| Label | URL |
|---|---|
| website of the Experimental Tuberculosis Unit, Fundacio Institut Germans Trias i Pujol | View source |
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Data obtained will be openly available through Mendeley Data, under CC BY 4.0 license.
Data set details:
Vilaplana, Cristina; Vashakidze, Sergo; Gogishvili, Shota; Nikolaishvili , Keti; Despuig, Albert; Benito, Pau; Avramopoulos, Asimakis; GarcÃa, Zaira; Téllez, Erica; Sarrias, Maria Rosa (2020), "SH-TBL project dataset", Mendeley Data, V1, doi: 10.17632/knhvdbjv3r.1
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Once the results will be published.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Apr 20, 2016 | Sep 8, 2020 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D014397 | Tuberculosis, Pulmonary |
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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For the prospective substudy only:
The following samples will be prospectively collected from patients undergoing therapeutical surgery:
| Change in Health Quality of Life Measurements | measured with Health Quality of Life Questionnaires; only for Prospective Substudy | at baseline (before surgery) and through study completion, an average of 1 year |
| Benito P, Vashakidze S, Gogishvili S, Nikolaishvili K, Despuig A, Tukvadze N, Shubladze N, Avaliani Z, Vilaplana C. Impact of adjuvant therapeutic surgery on the health-related quality of life of pulmonary tuberculosis patients. ERJ Open Res. 2020 Aug 31;6(3):00083-2020. doi: 10.1183/23120541.00083-2020. eCollection 2020 Jul. |
| 33149141 | Result | Moreira-Teixeira L, Stimpson PJ, Stavropoulos E, Hadebe S, Chakravarty P, Ioannou M, Aramburu IV, Herbert E, Priestnall SL, Suarez-Bonnet A, Sousa J, Fonseca KL, Wang Q, Vashakidze S, Rodriguez-Martinez P, Vilaplana C, Saraiva M, Papayannopoulos V, O'Garra A. Type I IFN exacerbates disease in tuberculosis-susceptible mice by inducing neutrophil-mediated lung inflammation and NETosis. Nat Commun. 2020 Nov 4;11(1):5566. doi: 10.1038/s41467-020-19412-6. |
| 32203062 | Result | Fonseca KL, Maceiras AR, Matos R, Simoes-Costa L, Sousa J, Ca B, Barros L, Fernandes AI, Mereiter S, Reis R, Gomes J, Tapia G, Rodriguez-Martinez P, Martin-Cespedes M, Vashakidze S, Gogishvili S, Nikolaishvili K, Appelberg R, Gartner F, Rodrigues PNS, Vilaplana C, Reis CA, Magalhaes A, Saraiva M. Deficiency in the glycosyltransferase Gcnt1 increases susceptibility to tuberculosis through a mechanism involving neutrophils. Mucosal Immunol. 2020 Sep;13(5):836-848. doi: 10.1038/s41385-020-0277-7. Epub 2020 Mar 13. |
| 33976135 | Derived | Moreno-Molina M, Shubladze N, Khurtsilava I, Avaliani Z, Bablishvili N, Torres-Puente M, Villamayor L, Gabrielian A, Rosenthal A, Vilaplana C, Gagneux S, Kempker RR, Vashakidze S, Comas I. Genomic analyses of Mycobacterium tuberculosis from human lung resections reveal a high frequency of polyclonal infections. Nat Commun. 2021 May 11;12(1):2716. doi: 10.1038/s41467-021-22705-z. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |